Clip applier

ABSTRACT

Medical devices and instruments, particularly appliers that may be used to apply occlusion devices such as occlusion clips on anatomical structures, are disclosed. Some example clip appliers may include an activation lever configured to open and close an occlusion clip releasably mounted in an end effector. Some example clip appliers may include a deployment trigger configured to release the occlusion clip from the end effector. Some example clip appliers may include a shaft extending between a handle and the end effector that is rotatable and/or bendable.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a claims priority to and is a continuation of U.S.Nonprovisional Application Ser. No. 16/190,417, filed Nov. 14, 2018, nowU.S. Pat. No. ______, which claimed the benefit of U.S. ProvisionalApplication No. 62/586,020, filed Nov. 14, 2017, and U.S. ProvisionalApplication No. 62/611,247, filed Dec. 28, 2017, all of which areincorporated by reference.

INTRODUCTION TO THE INVENTION

The present disclosure is directed to medical instruments and devices,and, more specifically, to appliers that may be used to apply occlusiondevices on anatomical structures, such as an occlusion clip on a leftatrial appendage of a heart.

It is a first aspect of the present disclosure to provide a medicalinstrument which may include a handle; an activation lever disposed onthe handle, the activation lever being movable between a closedactivation lever configuration and an open activation leverconfiguration by application of an external force to the activationlever; a shaft mounted to and extending distally from the handle; and/oran end effector disposed distally on the shaft. The end effector mayinclude a first jaw movable between a closed jaw configuration and anopen jaw configuration. The first jaw may be operatively coupled to theactivation lever such that moving the activation lever from the closedactivation lever configuration to the open activation leverconfiguration moves the first jaw from the closed jaw configuration tothe open jaw configuration. The activation lever and handle may includea track and a track follower configured to decrease an external forcerequired to move the activation lever from the closed activation leverconfiguration to the open activation lever configuration as theactivation lever moves from the closed activation lever configuration tothe open activation lever configuration. The first jaw may be configuredto releasably receive an occlusion clip.

In a more detailed embodiment of the first aspect, an external forcerequired to maintain the activation lever in the open activation leverconfiguration may be less than the external force required move theactivation lever from the closed activation lever configuration to theopen activation lever configuration. The external force required tomaintain the activation lever in the open activation lever configurationmay be less than about one half of the external force required move theactivation lever from the closed activation lever configuration to theopen activation lever configuration. An external force required move theactivation lever from the closed activation lever configuration to theopen activation lever configuration may be substantially constant forabout 85% of a length of travel from the closed activation leverconfiguration to the open activation lever configuration. The activationlever may be pivotably disposed on the handle and/or the first jaw maybe pivotably disposed on the end effector. The activation lever may beoperatively coupled to the first jaw by an activation cable extendingthrough the shaft.

In a more detailed embodiment of the first aspect, the medicalinstrument may include a linkage including a first end pivotablyattached to the activation lever and a second end having the trackfollower affixed thereto. The track may be disposed within the handleand/or may be configured to slidably receive the track follower. Theactivation cable may be mounted to the second end of the linkage andextends to the end effector through a channel in the shaft. Moving theactivation lever between the closed activation lever configuration andthe open activation lever configuration by application of the externalforce to the activation lever may move the track follower along thetrack from a first location to a second location. Moving the trackfollower from the first location to the second location may pull theactivation cable generally proximally. Pulling the activation cableproximally may cause the end effector to move the first jaw from theclosed jaw configuration to the open jaw configuration. The track may begenerally arcuately shaped. A pivot point of the activation lever, adirection of the activation cable generally between the second end ofthe linkage and the pivot point of the activation lever, and the trackfollower may be generally aligned when the activation lever is in theopen activation lever configuration.

In a more detailed embodiment of the first aspect, the medicalinstrument may include a spring operatively coupled to the activationlever and the linkage to bias the activation lever towards the closedactivation lever configuration. The medical instrument may include anocclusion clip releasably attached to the end effector. The occlusionclip may move from a closed occlusion clip configuration to an openocclusion clip configuration as the first jaw moves from the closed jawconfiguration to the open jaw configuration. The occlusion clip may bean open-ended occlusion clip. The occlusion clip may be biased towardthe closed occlusion clip configuration. When the activation lever is inthe open activation lever position and the external force is removed,the activation lever may move to the closed activation lever position,the track follower may move from the second location to the firstlocation, and the first jaw may move from the open jaw configuration tothe closed jaw configuration without application of an external force.

In a more detailed embodiment of the first aspect, the shaft may bemounted to the handle such that the shaft is selectively rotatablerelative to the handle. the handle and the shaft may each include areleasably engageable corresponding locking feature arranged toselectively inhibit rotation of the shaft relative to the handle.

In a more detailed embodiment of the first aspect, the shaft may beplastically deformable. The shaft may be plastically deformable up to anangle of at least about 45 degrees.

In a more detailed embodiment of the first aspect, the medicalinstrument may include an occlusion clip releasably attached to the endeffector and/or a deployment trigger disposed on the handle. Thedeployment trigger may be movable between a pre-deployment configurationand a deployment configuration by application of an external force tothe deployment trigger. The deployment trigger may be operable torelease the occlusion clip from the end effector.

In a more detailed embodiment of the first aspect, the medicalinstrument may include a deployment cable extending from the handle tothe first jaw. The deployment cable may be operative, when retracted, torelease an occlusion clip from the first jaw. The medical instrument mayinclude at least one of a thumbwheel disposed on the handle, thethumbwheel being operable to retract the deployment cable and releasethe occlusion clip; a deployment lever disposed on the handle, thedeployment lever being operable to retract the deployment cable andrelease the occlusion clip; a rotatable pull tab disposed on the handle,the pull tab being operable, after being rotated, to retract thedeployment cable and release the occlusion clip; or a torsion springcable retractor comprising a torsion spring arranged to apply proximaltension on deployment cable and a retainer arranged to selectivelyprevent retraction of deployment cable until the retainer is disengaged,the torsion spring cable retractor being operable to retract thedeployment cable and release the occlusion clip.

It is a second aspect of the present disclosure to provide s medicalinstrument including a handle; a deployment trigger disposed on thehandle, the deployment trigger being movable between a pre-deploymentconfiguration and a deployment configuration by application of anexternal force to the deployment trigger; a shaft mounted to andextending distally from the handle; and/or an end effector disposeddistally on the shaft, the end effector comprising a first jawconfigured to releasably receive an occlusion clip, the deploymenttrigger being operatively coupled to the first jaw by a deploymentcable. Moving the deployment trigger from the pre-deploymentconfiguration to the deployment configuration may retract the deploymentcable proximally, releasing the occlusion clip from the first jaw.

In a more detailed embodiment of the second aspect, the medicalinstrument may include an elastic member disposed within the handle. Theelastic member may include a first end and a second end, the second endbeing affixed to the handle. The deployment cable may extend from thefirst end of the elastic member to the first jaw. When the deploymenttrigger is in the pre-deployment configuration, the elastic member maybe held in an extended configuration. When the deployment trigger ismoved to the deployment configuration, the elastic member may retractthe deployment cable proximally. Retracting the deployment cableproximally may release the occlusion clip from the first jaw. Theelastic member may be an extension spring.

In a more detailed embodiment of the second aspect, the medicalinstrument may include a stop member affixed to the deployment cablebetween the first end of the elastic member and the shaft; and/or ananchoring plate disposed within the handle and arranged to selectivelyblock proximal movement of the stop member. When the deployment triggeris in the pre-deployment configuration, the elastic member may be heldin the extended configuration by the stop member abutting a distalsurface of an anchoring plate. The medical instrument may include adeployment trigger slot disposed on the deployment trigger, the slotslidably receiving the stop member therein. The anchoring plate may befixedly mounted to the handle. When the deployment trigger is in thepre-deployment configuration, the deployment trigger slot may be atleast partially aligned with the anchoring plate. When the deploymenttrigger is in the deployment configuration, the deployment trigger slotmay be aligned generally adjacent to the anchoring plate, therebyallowing the stop member to move proximally relative to the deploymenttrigger slot and the anchoring plate. 25. The anchoring plate mayinclude an anchoring plate slot that is wider than the deployment cableand narrower than the stop member. When the deployment trigger is in thepre-deployment configuration, the deployment trigger slot may begenerally aligned with the anchoring plate slot.

In a more detailed embodiment of the second aspect, the medicalinstrument may include a fixed slot disposed on the handle, the slotslidably receiving the stop member therein. The anchoring plate may bemovable relative to the fixed slot. The deployment trigger may beoperatively coupled to the anchoring plate. When the deployment triggeris in the pre-deployment configuration, the fixed slot may be alignedsuch that the stop member at least partially abuts the anchoring plate.When the deployment trigger is in the deployment configuration, thefixed slot may be aligned with an opening through the anchoring plate,thereby allowing the stop member to move proximally relative to thefixed slot and at least partially through the opening through theanchoring plate.

In a more detailed embodiment of the second aspect, the medicalinstrument may include a removable safety tab. The safety tab mayinclude a pin extending into the handle and arranged to prevent movementof the deployment trigger and a grip extending outwardly from thehandle.

In a more detailed embodiment of the second aspect, the shaft may bemounted to the handle such that the shaft is selectively rotatablerelative to the handle. The handle and/or the shaft may each include areleasably engageable corresponding locking feature arranged toselectively inhibit rotation of the shaft relative to the handle.

In a more detailed embodiment of the second aspect, the shaft may beplastically deformable. The shaft may be plastically deformable up to anangle of at least about 45 degrees.

In a more detailed embodiment of the second aspect, the medicalinstrument may include an activation lever disposed on the handle. Theactivation lever may be movable between a closed activation leverconfiguration and an open activation lever configuration by applicationof an external force to the activation lever. The end effector mayinclude a first jaw movable between a closed jaw configuration and anopen jaw configuration. The first jaw may be operatively coupled to theactivation lever such that moving the activation lever from the closedactivation lever configuration to the open activation leverconfiguration moves the first jaw from the closed jaw configuration tothe open jaw configuration.

It is a third aspect of the present disclosure to provide a medicalinstrument including a handle; a plastically deformable shaft mounted toand extending distally from the handle; and/or an end effector disposeddistally on the shaft and configured to releasably receive an occlusionclip thereon. The shaft may be mounted to the handle such that the shaftis selectively rotatable relative to the handle.

In a more detailed embodiment of the third aspect, the handle mayinclude a handle locking feature. The shaft may include a shaft lockingfeature corresponding to the handle locking feature. The handle lockingfeature and/or the shaft locking feature may be releasably engageable toselectively inhibit rotation of the shaft relative to the handle. Eitherthe handle locking feature or the shaft locking feature may include alocking recess including a plurality of inwardly facing locking recesslocking faces. The other of the handle locking feature or the shaftlocking feature may include a projecting locking boss including aplurality of radially outwardly facing locking boss faces. In a lockedconfiguration, the locking boss may be at least partially engaged withinthe locking recess, inhibiting rotation of the shaft relative to thehandle. The handle locking feature may include a generally octagonallyshaped locking recess disposed on a distal face of the handle. The shaftlocking feature may include a generally octagonally shaped, proximallyprojecting locking boss. The medical instrument may include a springoperatively disposed on the handle and the shaft to bias the shaft andthe handle toward the locked configuration.

In a more detailed embodiment of the third aspect, the shaft and/or thehandle may include a rotation limiting feature that prevents rotation ofthe shaft relative to the handle beyond a predetermined maximum amount.The rotation limiting feature may include, on the handle, a generallylongitudinally extending bar and/or on the shaft, a stop comprising atleast one stop face arranged to engage the bar and prevent furtherrotation when the shaft is rotated a predetermined maximum amount.

In a more detailed embodiment of the third aspect, the medicalinstrument may include a friction spring in a press fit engagement witha surface of the shaft, the friction spring including a tab engaging thehandle to prevent rotation of the friction spring relative to thehandle. The press fit engagement between the friction spring and thesurface of the shaft may oppose rotation of the shaft relative to thehandle but may allow such rotation when sufficient torque is applied tothe shaft.

In a more detailed embodiment of the third aspect, the shaft may includea proximally extending lock projection comprising a plurality of lockingfaces. The handle may include a locking spring arranged to elasticallyengage at least one of the locking faces. The elastic engagement of thelocking spring and the locking faces may oppose rotation of the shaftrelative to the handle but may allow such rotation when sufficienttorque is applied to the shaft.

In a more detailed embodiment of the third aspect, the shaft may includeat least one of aluminum, copper, stainless steel, and polycarbonate.The shaft may be deformable up to an angle of at least about 45 degrees.

In a more detailed embodiment of the third aspect, the medicalinstrument may include a deployment trigger disposed on the handle. Thedeployment trigger may be movable between a pre-deployment configurationand a deployment configuration by application of an external force tothe deployment trigger. The deployment trigger may be operable torelease an occlusion clip from the end effector.

In a more detailed embodiment of the third aspect, the end effector mayinclude a first jaw movable between a closed jaw configuration and anopen jaw configuration. The medical instrument may include an activationlever disposed on the handle. The activation lever may be movablebetween a closed activation lever configuration and an open activationlever configuration by application of an external force to theactivation lever. The first jaw may be operatively coupled to theactivation lever such that moving the activation lever from the closedactivation lever configuration to the open activation leverconfiguration moves the first jaw from the closed jaw configuration tothe open jaw configuration.

It is a fourth aspect of the present disclosure to provide method ofdeploying an occlusion clip including placing a clip applier in an openconfiguration by moving an activation lever of the clip applier from aclosed activation lever configuration to an open activation leverconfiguration by applying an external force to the activation lever;positioning an occlusion clip adjacent to an occlusion site, whichincludes deforming a shaft of the clip applier, the occlusion clip beingreleasably held by an end effector of the clip applier; placing the clipapplier in the closed configuration by moving the activation lever fromthe open configuration to the closed configuration; operating adeployment trigger on the clip applier to release the occlusion clipfrom the end effector; and/or withdrawing the end effector from theocclusion site, leaving the occlusion clip on the occlusion site.

In a more detailed embodiment of the fourth aspect, applying theexternal force to the activation lever may include decreasing the amountof external force as the activation lever moves from the closedactivation lever configuration to the open activation leverconfiguration. The method may include, while positioning the occlusionclip adjacent to the occlusion site, maintaining the clip applier in theopen configuration by continuing to apply the external force on theactivation lever, the force required for maintaining the clip applier inthe open configuration being less than the external force required formoving the activation lever from the closed activation leverconfiguration to the open activation lever configuration. The method mayinclude, before operating the deployment trigger to release theocclusion clip from the end effector, placing the clip applier in anopen configuration, repositioning the occlusion clip, and/or placing theclip applier in the closed configuration. Operating the deploymenttrigger to release the occlusion clip from the end effector may includemoving a cable stop relative to an anchoring plate to allow the cablestop to slide by the anchoring plate, thereby allowing proximal movementof a deployment cable affixed to the cable stop. The proximal movementof the deployment cable may release the occlusion clip from the endeffector. The method may include, before placing a clip applier in anopen configuration, rotating a shaft of the clip applier relative to ahandle of the clip applier, the end effector being mounted distally onthe shaft and the handle being mounted proximally on the shaft. Themethod may include, before placing a clip applier in an openconfiguration, plastically deforming a shaft of the clip applier, theend effector being mounted distally on the shaft and the handle beingmounted proximally on the shaft.

It is a fifth aspect of the present disclosure to provide a method ofdeploying an occlusion clip including positioning an occlusion clipadjacent to an occlusion site, the occlusion clip being releasablycoupled to an end effector of a clip applier by a deployment cable, thedeployment cable extending from the end effector to a handle of the clipapplier, the deployment cable having a cable stop fixedly attachedthereto; releasing the occlusion clip from the end effector by aligninga slot having the cable stop slidably therein from a pre-deploymentconfiguration generally aligned with an anchoring plate to a deploymentconfiguration to allow a spring attached to the deployment cable to pullthe deployment cable proximally; and withdrawing the end effector,leaving the occlusion clip on the occlusion site.

In a more detailed embodiment of the fifth aspect, aligning the slothaving the cable stop therein from the pre-deployment configurationgenerally aligned with the anchoring plate to the deploymentconfiguration may include aligning a movable slot having the cable stopslidably therein from a pre-deployment configuration generally alignedwith a fixed anchoring plate to a deployment configuration generallyaligned adjacent to the fixed anchoring plate. Aligning the slot havingthe cable stop therein from the pre-deployment configuration generallyaligned with the anchoring plate to the deployment configurationcomprises aligning a fixed slot having the cable stop therein from apre-deployment configuration generally aligned with a movable anchoringplate to a deployment configuration generally aligned through an openingin a movable anchoring plate. The method may include, before releasingthe occlusion clip from the end effector, removing a safety tab, thesafety tab preventing deployment of the occlusion clip. The method mayinclude, before placing a clip applier in an open configuration,rotating a shaft of the clip applier relative to a handle of the clipapplier, the end effector being mounted distally on the shaft and thehandle being mounted proximally on the shaft. The method may include,before positioning the occlusion clip adjacent to the occlusion site,plastically deforming a shaft of the clip applier, the shaft having theend effector mounted distally thereon and the handle mounted proximallythereon.

It is a sixth aspect of the present disclosure to provide a method ofoperating a medical device including rotating and deforming a shaft of aclip applier relative to a handle of the clip applier, the clip appliercomprising the handle, the shaft selectively rotatably mounted distallyon the handle, and an end effector mounted distally on the shaft, theend effector having an occlusion clip releasably mounted thereto;positioning the occlusion clip adjacent to an occlusion site; deployingthe occlusion clip from the end effector by actuating a deploymenttrigger on the handle; and/or withdrawing the end effector, leaving theocclusion clip on the occlusion site.

In a more detailed embodiment of the sixth aspect, a rotating the shaftof the clip applier relative to the handle of the clip applier mayinclude disengaging a shaft locking feature from a handle lockingfeature, rotating the shaft relative to the handle, and/or engaging theshaft locking feature with the handle locking feature. Disengaging ashaft locking feature from a handle locking feature may include applyinga generally distal force on the shaft and/or moving the shaft distallyrelative to the handle. Engaging the shaft locking feature with thehandle locking feature may include releasing the generally distal forceon the shaft and/or allowing a spring to pull the shaft proximallytoward the handle.

In a more detailed embodiment of the sixth aspect, rotating the shaftrelative to the handle may include rotating the shaft relative to thehandle until a rotation limiting feature prevents further rotation.

In a more detailed embodiment of the sixth aspect, the method mayinclude, before positioning the occlusion clip adjacent to the occlusionsite, plastically deforming the shaft. The method may include, beforepositioning the occlusion clip adjacent to the occlusion site, placingthe clip applier in an open configuration by moving an activation leverof the clip applier from a closed activation lever configuration to anopen activation lever configuration by applying an external force to theactivation lever; and/or before deploying the occlusion clip from theend effector, placing the clip applier in the closed configuration bymoving the activation lever from the open configuration to the closedconfiguration. The occlusion clip may be releasably mounted to the endeffector by a deployment cable, the deployment cable extending from theend effector, through the shaft, and to the handle. The deployment cablemay be coupled to an extended extension spring within the handle. Acable stop may be disposed on the deployment cable. Actuating adeployment trigger on the handle may include aligning a movable slothaving the cable stop slidably therein from a pre-deploymentconfiguration generally aligned with a fixed anchoring plate to adeployment configuration generally aligned adjacent to the fixedanchoring plate, thereby allowing the cable stop to move by theanchoring plate, and allowing the spring to retract the deploymentcable.

It is a seventh aspect of the present disclosure to a method ofdeploying an occlusion clip including placing a clip applier in an openconfiguration by moving an activation lever of the clip applier from aclosed activation lever configuration to an open activation leverconfiguration by applying an external force to the activation lever;positioning an occlusion clip adjacent to an occlusion site; placing theclip applier in the closed configuration by moving the activation leverfrom the open configuration to the closed configuration; operating adeployment trigger on the clip applier to release the occlusion clipfrom the end effector; and/or withdrawing the end effector from theocclusion site, leaving the occlusion clip on the occlusion site.

In a more detailed embodiment of the seventh aspect, applying theexternal force to the activation lever may include decreasing the amountof external force as the activation lever moves from the closedactivation lever configuration to the open activation leverconfiguration. The method may include, while positioning the occlusionclip adjacent to the occlusion site, maintaining the clip applier in theopen configuration by continuing to apply the external force on theactivation lever, the force required for maintaining the clip applier inthe open configuration being less than the external force required formoving the activation lever from the closed activation leverconfiguration to the open activation lever configuration. The method mayinclude, before operating the deployment trigger to release theocclusion clip from the end effector, placing the clip applier in anopen configuration, repositioning the occlusion clip, and/or placing theclip applier in the closed configuration. Operating the deploymenttrigger to release the occlusion clip from the end effector may includemoving a cable stop relative to an anchoring plate to allow the cablestop to slide by the anchoring plate, thereby allowing proximal movementof a deployment cable affixed to the cable stop. The proximal movementof the deployment cable may release the occlusion clip from the endeffector. The method may include, before placing a clip applier in anopen configuration, rotating a shaft of the clip applier relative to ahandle of the clip applier, the end effector being mounted distally onthe shaft and the handle being mounted proximally on the shaft. Themethod may include, before placing a clip applier in an openconfiguration, plastically deforming a shaft of the clip applier, theend effector being mounted distally on the shaft and the handle beingmounted proximally on the shaft.

It is an eighth aspect of the present disclosure to provide a method ofdeploying an occlusion clip including placing a clip applier in an openconfiguration by moving an activation lever of the clip applier from aclosed activation lever configuration to an open activation leverconfiguration; positioning an occlusion clip adjacent to an occlusionsite, the occlusion clip being releasably mounted in an end effector ofthe clip applier; placing the clip applier in a closed configuration bymoving the activation lever from the open activation lever configurationto the closed activation lever configuration; operating a deploymenttrigger on the clip applier to release the occlusion clip from the endeffector; and withdrawing the end effector from the occlusion site,leaving the occlusion clip on the occlusion site without puncturing theocclusion site.

In a more detailed embodiment of the eighth aspect, the method mayinclude rotating and deforming a shaft of the clip applier relative to ahandle of the clip applier, the clip applier comprising the handle, theshaft selectively rotatably mounted distally on the handle, and the endeffector mounted distally on the shaft.

BRIEF DESCRIPTION OF THE DRAWINGS

Example embodiments are described in conjunction with the accompanyingdrawing figures in which:

FIG. 1 is a side elevation view of an example clip applier in a closedconfiguration;

FIG. 2 is a side elevation view of an example clip applier in an openconfiguration;

FIG. 3 is detailed perspective view of an example occlusion clip beingdeployed on an anatomical structure;

FIG. 4 is detailed perspective view of an example occlusion clip beingdeployed on an anatomical structure;

FIG. 5 is detailed perspective view of an example occlusion clip beingdeployed on an anatomical structure;

FIG. 6 is an interior side elevation view of an example handle in aclosed configuration;

FIG. 7 is an interior side elevation view of an example handle in anopen configuration;

FIG. 8 is a perspective view of an example activation lever mechanism;

FIG. 9 is a detailed interior perspective view of an example endeffector;

FIG. 10 is a side elevation view of an example end effector showingtip-first closure of an occlusion clip;

FIG. 11 is an interior perspective view of an example clip applierhandle showing occlusion clip release components in a before deploymentconfiguration;

FIG. 12 is an interior perspective view of an example clip applierhandle showing occlusion clip release components in a during deploymentconfiguration;

FIG. 13 is an interior perspective view of an example clip applierhandle showing occlusion clip release components in an after deploymentconfiguration;

FIG. 14 is an elevation view of an example deployment cable;

FIG. 15 is a detailed perspective view of a distal portion of an examplehandle;

FIG. 16 is a detailed perspective view of a proximal portion of anexample shaft;

FIG. 17 is a detailed internal perspective view of an example shaft andhandle in a locked configuration;

FIG. 18 is a detailed internal perspective view of an example shaft andhandle in an unlocked configuration;

FIG. 19 is an internal perspective view of a distal portion of anexample handle with an example shaft in a rotated configuration;

FIG. 20 is a side elevation view of an example clip applier with a shaftin a bent configuration;

FIG. 21 is a detailed internal perspective view of alternative exampleocclusion clip release components in a during deployment configuration;

FIG. 22 is a perspective view of an alternative example deploymentbutton;

FIG. 23 is a perspective view of an alternative example deploymentbutton;

FIG. 24 is a perspective view of an alternative example deploymentbutton;

FIG. 25 is a perspective view of an example thumbwheel deployment cableretractor;

FIG. 26 is a perspective view of an example lever actuated deploymentcable retractor;

FIG. 27 is a perspective view of an example pull tab deployment cableretractor;

FIG. 28 is a side elevation view of an alternative example clip applierincluding a torsion spring cable retractor;

FIG. 29 is side elevation view of an example crimp plate method ofattaching a deployment cable to a torsion spring;

FIG. 30 is side elevation view of an example solder method of attachinga deployment cable to a torsion spring;

FIG. 31 is side elevation view of an example fastener method ofattaching a deployment cable to a torsion spring;

FIG. 32 is a detailed perspective view of an alternative shaft rotationfeature including a friction spring;

FIG. 33 is a detailed perspective view of an alternative shaft rotationfeature including a detent mechanism;

FIG. 34 is a perspective view of an example clip applier including alateral safety tab;

FIG. 35 is a perspective view of an example clip applier including alongitudinal safety tab;

FIG. 36 is an interior perspective view of an example shell of a handle;and

FIG. 37 is an interior perspective view of an example shell of a handle;all in accordance with at least some aspects of the present disclosure.

DETAILED DESCRIPTION

Example embodiments according to the present disclosure are describedand illustrated below to encompass devices, methods, and techniquesrelating to surgical procedures. Of course, it will be apparent to thoseof ordinary skill in the art that the embodiments discussed below areexamples and may be reconfigured without departing from the scope andspirit of the present disclosure. It is also to be understood thatvariations of the example embodiments contemplated by one of ordinaryskill in the art shall concurrently comprise part of the instantdisclosure. However, for clarity and precision, the example embodimentsas discussed below may include optional steps, methods, and featuresthat one of ordinary skill should recognize as not being a requisite tofall within the scope of the present disclosure.

The present disclosure includes, inter alia, medical devices andinstruments, and, more specifically, appliers that may be used to applyocclusion devices on anatomical structures. The present disclosurecontemplates that, in some circumstances, it may be desirable to occludean anatomical structure by placing an occlusion device, such as anocclusion clip, on the anatomical structure. For example, in somepatients with atrial fibrillation, stagnant blood in the heart's leftatrial appendage (“LAA”) may be a source of blood clots, which may enterthe blood circulation and increase the risk of stroke. In some patients,it may be desirable to occlude the LAA by securely sealing the LAAorifice at the base of the LAA in an effort to reduce this risk withoutpuncturing the LAA.

FIGS. 1 and 2 are side elevation views of an example clip applier 100 ina closed configuration and an open configuration, respectively,according to at least some aspects of the present disclosure. Clipapplier 100 may include a handle 200, a shaft 300 extending generallydistally from handle 200, and/or an end effector 400 disposed generallydistally on shaft 300. An occlusion clip 1000 may be releasably attachedto end effector 400. As used herein, “distal” may refer to a directiongenerally toward end effector 400 and “proximal” may refer to adirection generally toward handle 200.

In some example embodiments according to at least some aspects of thepresent disclosure, end effector 400 may include jaws 402, 404, whichmay be configured to engage respective arms 1002, 1004 of occlusion clip1000. One or both jaws 402, 404 and respective arms 1002, 1004 may bemovable from a closed configuration in which jaws 402, 404 and arms1002, 1004 are generally parallel (FIG. 1) to an open configuration inwhich one jaw 402 and its associated arm 1002 is nonparallel relative tothe other jaw 404 and its associated arm 1004 (FIG. 2).

In some example embodiments according to at least some aspects of thepresent disclosure, handle 200 may include a grip 202, which may begenerally shaped to be held in a user's hand, such as in a pistol gripfashion. Handle 200 may include an activation lever 204, which may beused to shift clip applier 100 from the closed configuration (FIG. 1) tothe open configuration (FIG. 2) and from the open configuration (FIG. 2)to the closed configuration (FIG. 1). For example, when in the closedconfiguration (FIG. 2), moving activation lever 204 toward grip 202(generally proximally) may shift clip applier 100 to the openconfiguration (FIG. 2). When in the open configuration (FIG.1), movingactivation lever 204 away from grip 202 (generally distally) may shiftclip applier 100 to the closed configuration (FIG. 1). In some exampleembodiments, activation lever 204 may be biased away from grip 202,which may place clip applier 100 in the closed configuration (FIG. 1)when external forces, such as from hand grasping of lever 204 and grip202, are removed from activation lever 204. Portions of handle 200 maybe constructed of one or more shells 201, 203.

In some example embodiments according to at least some aspects of thepresent disclosure, handle 200 may include a deployment trigger 206,which may be used to deploy occlusion clip 1000. For example, movingdeployment trigger 206 generally proximally via rotation or slidingmotion may release occlusion clip 1000 from end effector 400.

In some example embodiments according to at least some aspects of thepresent disclosure, the shaft 300 may include a shaft rotation knob 302,which may be operable to selectively allow or prevent rotation of shaft300 relative to handle 200. For example, moving knob 302 distally(toward end effector 400) may permit rotation of knob 302 and shaft 300about shaft's 300 longitudinal axis. Moving knob 302 proximally(generally toward grip 202) may prevent rotation of shaft 300 relativeto handle 200.

FIGS. 3-5 are detailed perspective views of an occlusion clip 1000 beingdeployed on an anatomical structure 1100 according to at least someaspects of the present disclosure. Referring to FIGS. 1-5, some exampleclip appliers 100 according to at least some aspects of the presentdisclosure may be used as follows. Clip applier 100, with occlusion clip1000 attached, may be placed in an open configuration by operatingactivation lever 204 and positioned to locate occlusion clip 1000adjacent an occlusion site 1102 on an anatomical structure 1100 (FIGS. 2and 3). Clip applier 100 may be placed into the closed configuration byoperating activation lever 204, and the positioning of occlusion clip1000 at the occlusion site 1102 of the anatomical structure 1100 may beverified (FIGS. 1 and 4). If necessary, clip applier 100 may be returnedto the open configuration by operating activation lever 204 (FIGS. 2 and3), repositioned, and returned to the closed configuration by operatingactivation lever 204 (FIGS. 1 and 4). Deployment trigger 206 (FIGS. 1and 2) may be operated to deploy occlusion clip 1000, which may releaseocclusion clip 1000 from end effector 400. Clip applier 100 may be movedto withdraw end effector 400 from the anatomical structure 1100, leavingocclusion clip 1000 on occlusion site 1102 of the anatomical structure1100 (FIG. 5). Occlusion clip 1000 may remain as a permanent implant onanatomical structure 1100. In some example embodiments according to atleast some aspects of the present disclosure, anatomical structure 1100may be occluded by clip 1000 without being punctured.

The present disclosure contemplates that some occlusion deviceapplicators may require one hand to hold the applicator and another handto release the occlusion device from the applicator. For example, thepresent disclosure contemplates that some occlusion device applicatorsmay utilize an occlusion clip release mechanism that requires manualcutting (e.g., with a scalpel) of sutures attaching the occlusion clipto the applicator. The present disclosure contemplates that, in somecircumstances, it may be advantageous to avoid utilizing a sharpinstrument, such as a scalpel or scissors, near a patient's heart or asurgeon's hand. The present disclosure contemplates that some occlusiondevice applicators may require a user to pull deployment cables awayfrom the applicator to deploy the occlusion device. The presentdisclosure contemplates that, in some circumstances, it may beadvantageous to avoid relatively large movements.

The present disclosure contemplates that, in some circumstances, it maybe desirable to provide an occlusion device applicator that may be bothheld and operated by one hand. For example, during some LAA occlusionprocedures, a surgeon's left hand may be used to support the patient'sheart while the surgeon's right hand may be used to hold, position,and/or actuate the occlusion device applicator.

Some example clip appliers 100 according to at least some aspects of thepresent disclosure may be configured to permit one-handed operation.Some example clip appliers 100 may be held in one hand, shifted betweenthe open and closed configurations by the holding hand, and/or actuatedto deploy occlusion clip 1000 by the holding hand. For example, someclip appliers 100 according to at least some aspects of the presentdisclosure may be configured for operation of activation lever 204 byone or more fingers of the holding hand. Some example clip appliers 100according to at least some aspects of the present disclosure may beconfigured for operation of deployment trigger 206 by one finger, suchas the holding hand's index finger.

FIGS. 6 and 7 are interior side elevation views of an example handle 200in a closed configuration and an open configuration, respectively,according to at least some aspects of the present disclosure. FIG. 8 isa perspective view of an example activation lever 204 mechanism,according to at least some aspects of the present disclosure. In someexample embodiments, activation lever 204 may be mounted to rotate aboutactivation lever pivot journals 236, 237. For example, activation leverpivot journal 236 may rotatably engage a bearing 205 disposed on shell203 of handle 200 (FIG. 37) and a pivot journal 237 may rotatably engagea bearing 207 disposed on shell 201 of handle 200 (FIG. 36). Activationlever 204 may be operatively coupled to jaws 402, 404 of end effector400 (FIGS. 1 and 2) by an activation cable 210. Activation cable 210 mayextend through the interior of handle 200 and through a hollow channelextending through shaft 300 to end effector 400 (FIGS. 1 and 2).

Referring to FIGS. 6-8, in some example embodiments, activation lever204 may be operatively coupled to activation cable 210 by a linkage 212.A first end 214 of linkage 212 may be pivotably attached to activationlever 204, such as by a rivet 216. In some example embodiments, atorsion spring 215 may be mounted to activation lever 204 and linkage212 near rivet 216 such that linkage 212 is torsionally biased to rotatetowards activation lever pivot journal 236, which may bias activationlever 204 toward the open configuration (FIGS. 1 and 6). A second end218 of linkage 212 may be attached to activation cable 210, such as bylooping activation cable 210 around a fastener 220 (e.g., a screw)extending through linkage 212 and installing a crimp tube 222 onactivation cable 210. In some example embodiments, a track follower 224(e.g., a bushing) may be affixed to second end 218 of linkage 212, suchas by fastener 220.

In some example embodiments, track follower 224 may be slidably disposedalong a track 226 within handle 200. Track 226 may be formed by a firstsidewall 228 spaced apart from a second sidewall 230 to slidably receivetrack follower 224 therebetween. In some example embodiments, firstsidewall 228 and/or second sidewall 230 may be formed as part of handle200 shell 201. First sidewall 228 and second sidewall 230 may definetrack 226 in a nonlinear shape, such as a generally curved, arcuateshape.

In some example embodiments, moving activation lever 204 from the closedconfiguration (FIG. 6) to the open configuration (FIG. 7), such as by auser applying a generally proximal force to activation handle (such asby squeezing activation handle 204 towards grip 202 with the fingers),may cause track follower 224 to move within track 226 from a firstlocation 232 to a second location 234. Such movement may pull activationcable 210 generally proximally (e.g., generally away from end effector400) through shaft 300. Such proximal movement of activation cable 210may cause jaws 402, 404 of end effector 400 to move from the closedconfiguration (FIG. 1) to the open configuration (FIG. 2). Reducingand/or removing the user-applied proximal force applied to activationhandle 204 may allow activation handle 204, track follower 224, andactivation cable 210 to return to the closed configuration, such as bythe action of torsion spring 215 and/or a closed-biased occlusion clip1000.

The present disclosure contemplates that some occlusion deviceapplicators may utilize a mechanical lock and/or a sustaineduser-applied force to hold an occlusion device (e.g., an occlusion clip)open while positioning the occlusion device on an anatomical structure,such as a LAA. The present disclosure contemplates that while amechanical lock may effectively hold the occlusion device open duringpositioning, such a mechanism may require a cumbersome unlocking action(e.g., disengaging an inconveniently located lock) to permit closureand/or deployment of the occlusion device. For example, on some devices,it may be necessary for a user to visually locate the lock so that itmay be activated and/or deactivated. The present disclosure contemplatesthat some occlusion device applicators relying on sustained user-appliedforce to keep the occlusion device open may avoid some of thedisadvantages of mechanical locks; however, the user may experiencedisadvantages such as fatigue and/or compromised dexterity if therequired force is high.

Referring to FIGS. 6-8, as will be apparent to one of skill in the art,the length of linkage 212 between rivet 216 and track follower 224, thelength of activation lever 204 between activation lever pivot journal236 and rivet 216, and/or the location and/or shape of track 226 betweenfirst location 232 and second location 234 may affect the force thatmust be applied by a user over the travel of activation lever 204. Insome example embodiments, it may be desirable to limit the cam angle tomaintain smooth operation, particularly in portions of travel ofactivation lever 204 where forces are higher. For example, the curvatureof track 226 may be limited to cause a generally straighter motion oftrack follower 224 in portions of travel of activation lever 204 whereforces are higher. As will be apparent to one of skill in the art,varying the configuration of these various components may vary the forceand distance output of the mechanism as activation lever 204 travelsbetween the open configuration and closed configuration.

Some example embodiments according to at least some aspects of thepresent disclosure may be configured to require less user-applied forceon activation lever 204 near the end of its travel, such as when clipapplier is near and/or in the open configuration. For example, the pivotpoint of activation lever 204 (activation lever pivot journal 236), thedirection of activation cable 210 generally between fastener 220 andactivation lever pivot journal 236, and track follower 224 may be nearlyaligned as activation lever 204 approaches the open configuration, whichmay increase the mechanical advantage and/or reduce the required forceon activation lever 204.

In some example embodiments according to at least some aspects of thepresent disclosure, a clip applier 100 may be configured to utilize auser-applied hold-open force to maintain the open configuration (FIG. 2)that is less than the force required to shift to the open configuration(FIG. 2) from the closed configuration (FIG. 1). Some example clipappliers 100 may require application of a generally constant force toactivation lever 204 to shift from the open configuration (FIG. 1)toward the closed configuration (FIG. 2) for a substantial portion(e.g., for about 85%) of the length of travel of activation lever 204.Then, for the travel remaining (e.g., about 15%), the force required tocontinue to the open configuration (FIG. 2), and/or the force requiredto hold activation lever 204 in the open configuration (FIG. 2), may beless than about half of the force required to begin the shift fromclosed configuration (FIG. 1) to the open configuration (FIG. 2).

In some example embodiments, activation lever 204 may reach a hard stopwhen clip applier 100 is in the fully open configuration (FIG. 2), whichmay indicate to the user that clip applier 100 is in the openconfiguration (FIG. 2) and/or that no additional force or travel may berequired. For example, as shown in FIGS. 2 and 7, a proximal surface ofactivation lever 204 may contact a distal surface of grip 202.

In some example embodiments, an activation mechanism may include alocking feature, which may be configured to hold clip applier 100 in theopen configuration (FIG. 20). For example, a lock similar to thatdescribed in described in U.S. Patent Application Publication No.2017/0014135, published Jan. 19, 2017, which is incorporated byreference, may be utilized.

FIG. 9 is a detailed interior perspective view of an example endeffector 400 and FIG. 10 is a side elevation view of an example endeffector 400 showing tip-first closure of an example occlusion clip1000, according to at least some aspects of the present disclosure. Insome example embodiments, jaws 402, 404 and respective arms 1002, 1004of occlusion clip 1000 (prior to deployment) may be shifted between theclosed configuration (FIG. 1) and the open configuration (FIG. 2) by theretraction (e.g., pulling in a proximal direction) or extension (e.g.,allowing movement in a distal direction) of activation cable 210, whichmay be effected by operation of activation handle 204 (FIGS. 6 and7).

In some example embodiments according to at least some aspects of thepresent disclosure, jaw 402 may be pivotably mounted to a pivot pin 406,and jaw 404 may be pivotably mounted to a pivot pin 408. Pivot pins 406,408 may be affixed to end effector 400 housing 410. End effector 400housing 410 may include two mirror-image portions, one of which is notshown in FIG. 9 for clarity. Activation cable 210 may extend distallyfrom handle 200 (FIGS. 6 and 7), through shaft 300, and to adouble-tackle pulley mechanism operatively disposed on the proximalportions 412, 414 of jaws 402, 404, respectively. Proximal movement ofactivation cable 210, such as by movement of activation lever 204 fromthe closed configuration to the open configuration (FIGS. 6 and 7), maycause the length of the activation cable 210 extending between pulleys416, 418 to decrease, thereby causing proximal ends 412, 414 of jaws402, 404 to move toward one another. This movement of proximal ends 412,414 of jaws 402, 404 toward one another may coincide with distal ends420, 422, respectively, of jaws 402, 404 pivoting away from one anotherabout to effectively open jaws 402, 404 and correspondingly openingocclusion clip 1000. Distal movement of activation cable 210, such as bymovement of activation lever 204 from the open configuration to theclosed configuration (FIGS. 6 and 7), may cause the length of theactivation cable 210 extending between pulleys 416, 418 to increase(such as by action of torsion spring 215 (FIG. 8) and/or a closed-biasedocclusion clip 1000), thereby allowing proximal ends 412, 414 of jaws402, 404 to move away from one another. This movement of proximal ends412, 414 of jaws 402, 404 apart may coincide with distal ends 420, 422,respectively, of jaws 402, 404 pivoting towards one another about toeffectively close jaws 402, 404 and correspondingly closing occlusionclip 1000.

Referring to FIG. 10, arm 1004 of occlusion clip 1000 may be attached tojaw 404, such as by sutures 426, 428, which may be disposed proximallywith respect to the center of the length of arm 1004 to cause the distaltips of occlusion clip 1000 close first when clip applier 100 (FIGS. 1and 2) is shifted from the open configuration (FIG. 2) to the closedconfiguration (FIG. 1).

U.S. Published Patent Application No. 2018/0036007, published Feb. 8,2018, and which is incorporated by reference, provides further detailsregarding the construction and operation of end effectors 400 that maybe operated by an activation cable 210 (“control wire”) that may be fedaround pulleys and utilized to cause jaws 402, 404 to pivot for openingand closing.

It is within the scope of the present disclosure to utilize alternativejaw opening mechanisms as known in the art, such as cams, gears, and/orlinkages, in connection with example embodiments according to at leastsome aspects of the present disclosure. It is within the scope of thepresent disclosure utilize jaw opening mechanisms described in U.S.Patent Application Publication No. 2017/0014135, published Jan. 19,2017, which is incorporated by reference.

FIGS. 11-13 are interior perspective views of an example handle 200showing occlusion clip release components in before deployment, duringdeployment, and after deployment configurations, respectively, allaccording to at least some aspects of the present disclosure. Deploymenttrigger 206 may be actuated by a user pressing generally proximally on atrigger face 207. Deployment trigger 206 may be operatively coupled tojaws 402, 404 of end effector 400 (FIGS. 1 and 2) by a deployment cable250, which may extend from handle 200 to end effector 400 through ahollow channel extending through shaft 300. A proximal end 252 ofdeployment cable 250 may be coupled to a first end 254 of an elasticmember, such as an extension spring 256. A second end 255 of extensionspring 256 may be affixed to the interior of handle 200, such as at aboss 258 formed in shell 201. Deployment cable 250 may extend from firstend 254 of extension spring 256, through a slot 260 in an anchoringplate 262, and to a cable stop, such as a crimp sleeve 264. Anchoringplate 262 may be fixedly mounted to shells 201, 203 by extending intoanchoring plate slots 213, 215, respectively (FIGS. 36 and 37). Slot 260in anchoring plate 262 may be wider than deployment cable 250 andnarrower than crimp sleeve 264, thereby allowing deployment cable 250 topass through slot 260 while preventing crimp sleeve 264 from passingthrough slot 260. Crimp sleeve 264 may be fixedly attached to deploymentcable 250, which may form a loop at proximal end 252 of deployment cable250. Deployment cable 250 may extend distally from the crimp sleeve 264through shaft 300 to end effector 400 (FIGS. 1 and 2).

In some example embodiments, deployment trigger 206 may be configured topivot with respect to handle shells 201, 203, such as by a deploymenttrigger pivot journal 266 pivotably engaging a bearing 209 disposed onshell 203 of handle 200 (FIG. 37) and a second deployment trigger pivotjournal (not shown) engaging a bearing 211 disposed on shell 201 ofhandle 200 (FIG. 36). Deployment trigger 206 may include a slot 268configured to slidably receive crimp sleeve 264 of deployment cable 250.For example, slot 268 may be at least partially defined by a first wall270 and a second wall 272 spaced apart to accept crimp sleeve 264therebetween.

Referring to FIG. 11, which illustrates an example before deploymentconfiguration according to at least some aspects of the presentdisclosure, deployment trigger 206 may be positioned in a pre-deploymentconfiguration with slot 268 of deployment trigger 206 generally alignedwith slot 260 of anchoring plate 262. Extension spring 256 may besubstantially extended and may apply a pulling force on proximal end 252of deployment cable 250. A proximal end of crimp sleeve 264 (which maybe fixedly attached to deployment cable 250 at a fixed position) may atleast partially abut a distal surface of anchoring plate 262. Becausecrimp sleeve 264 may be unable to pass through slot 260 in anchoringplate 262, extension spring 256 may be held in its extendedconfiguration. In the before deployment configuration, deploymenttrigger 206 may be actuated by a user pressing generally proximally ontrigger face 207, such as by a pulling or squeezing motion of the user'sindex finger.

Referring to FIG. 12, which illustrates an example during deploymentconfiguration according to at least some aspects of the presentdisclosure, deployment trigger 206 may be rotated from the beforedeployment configuration (FIG. 11) to a deployment configuration inwhich slot 268 of deployment trigger 206 is aligned generally adjacentto anchoring plate 262. In some example embodiments, rotating deploymenttrigger 206 to the deployment configuration may move crimp sleeve 264relative to anchoring plate 262. With slot 268 of deployment trigger 206aligned generally adjacent to anchoring plate 262, crimp sleeve 264 mayno longer be restrained by anchoring plate 262. The tensile forceexerted by extension spring 256 on deployment cable 250 may cause crimpsleeve 264 to slide generally proximally from within slot 268 ofdeployment trigger 206 by anchoring plate 262.

Referring to FIG. 13, which illustrates an example after deploymentconfiguration according to at least some aspects of the presentdisclosure, extension spring 256 may be in a relaxed configurationand/or deployment cable 250 may be retracted proximally to a position inwhich crimp sleeve 264 has cleared anchoring plate 262. Deployment cable250 may extend through slot 260 in anchoring plate 262 and/or throughslot 268 in deployment trigger 206. In some example embodiments,deployment cable 250 may be retracted by the force of extension spring256 about 5 cm (about 2 inches). Compare the position of crimp sleeve264 in FIG. 11 and FIG. 13, for example.

Referring to FIGS. 11-13, in some example embodiments, deploymenttrigger 206, anchoring plate 262, and related components may beconfigured to reduce the likelihood of unintentional actuation, such asdue to handling of the device. For example, deployment trigger 206 maybe located on handle 200 where it may be unlikely to be inadvertentlyactuated, deployment trigger 206 may be protected, such as by a triggerguard (see, e.g., FIG. 26), actuation of deployment trigger 206 mayrequire removal or disabling a safety device (see, e.g., FIGS. 34 and35), and/or the force and/or travel required actuate deployment trigger206 may reduce the likelihood of unintentional actuation.

In some example embodiments, the amount of tensile force exerted ondeployment cable 250 by spring 256 and/or the angle at which theproximal end of crimp sleeve 264 contacts the distal face of anchoringplate 262 may affect the force that must be applied to trigger face 207to shift deployment trigger 206 to cause crimp sleeve 264 to clearanchoring plate 262. As another example, the depth of slot 260 inanchoring plate 262 and/or the angle of pull of deployment cable 250 onthe proximal side of anchoring plate 262 may affect the distance thatslot 268 of deployment trigger 206 must move to cause crimp sleeve 264to clear anchoring plate 262. Similarly, the relative lengths ofdeployment trigger 206 between each of trigger face 207 and slot 268 andthe pivot point of deployment trigger 206 (e.g., trigger pivot journal266) may affect the distance that trigger face 207 must be moved by auser to cause crimp sleeve 264 to clear anchoring plate 262, as well asthe force that must be applied to trigger face 207. In some exampleembodiments, deployment trigger 206, anchoring plate 262, and relatedcomponents may be configured to require a force of about two and aboutten pounds on trigger face 207 and/or a distance of travel of triggerface 207 of about 0.5 cm (about 0.2 inches).

Some example embodiments according to at least some aspects of thepresent disclosure may provide tactile and/or audible indications thatdeployment trigger 206 and related components have been successfullyactuated, thus releasing occlusion clip 1000 from end effector 400. Insome example embodiments, inertia from extension spring 256 hitting itsstop location may provide tactile and/or audible indications that thedeployment mechanism has been actuated. Some example embodiments mayinclude a noise-producing component, such as a bell.

It is within the scope of the present disclosure to utilize elasticmembers other than extension springs, such as elastomers (e.g., silicon,rubber, latex, neoprene, and/or polyurethane). Some example embodimentsmay utilize alternative springs, such as compression springs, leafsprings, and/or constant force springs, for example.

FIG. 14 is an elevation view of an example deployment cable 250according to at least some aspects of the present disclosure. Deploymentcable 250 may include a first strand 251 and/or a second strand 253extending distally from crimp sleeve 264. In some example embodiments,deployment cable 250 may be constructed from a length of cable bent nearits center to form a loop at proximal end 252 for attachment toextension spring 256 (FIGS. 11-13). First strand 251 may extend throughshaft 300 to jaw 402, ending at a first strand end 255. Second strand253 may extend through shaft 300 to jaw 404, ending at a second strandend 257. In some example deployment cables 250 including first strand251 and second strand 253, pulling on proximal end 252 (such as byextension spring 256 (FIGS. 11-13)) may cause first strand end 255 andsecond strand end 257 to move proximally generally in parallel.

Referring to FIG. 9, a detailed interior perspective view of an exampleend effector 400 according to at least some aspects of the presentdisclosure, first strand 251 and second strand 253 of deployment cable250 may extend distally from handle 200, through shaft 300, to endeffector 400. The following description focuses on jaw 404 and secondstrand 253; however, jaw 402 and first strand 251 may be configured andoperate in a substantially similar manner.

In some example embodiments, second strand 253 of deployment cable 250may extend distally within jaw 404 within a channel 424. One or more ofsuture loops 426, 428 (e.g., retainer loops) may be longitudinallyspaced apart, may extend around arm 1004 of occlusion clip 1000, and/ormay extend through respective openings 430, 432 through jaw 404. Secondstrand 253 of deployment cable 250 may extend longitudinally througheach suture loop 426, 428. In this fashion, arm 1004 of occlusion clip1000 may be inhibited from detaching from jaw 404 until second strand253 is withdrawn from suture loops 426, 428 (e.g., retractedproximally).

In some example embodiments, to release occlusion clip 1000 from endeffector 400, deployment cable 250 is repositioned proximally (such asby actuating deployment trigger 206 to allow extension spring 256 towithdraw cable 250 proximally) and second strand 253 discontinuesengagement with the suture loops 426, 428 that were previouslyconcurrently attached to occlusion clip 1000 and jaw 404. When theengagement between strand 253 and the suture loops 426, 428 isdiscontinued, suture loops 426, 428 may be pulled through respectiveopenings 430, 432 toward arm 1004 to free arm 1004 of occlusion clip1000 from jaw 404.

U.S. Published Patent Application No. 2018/0036007, published Feb. 8,2018 and which is incorporated by reference, provides further detailsregarding the construction and operation of end effectors 400 holdingocclusion clips 1000 that may be released by withdrawing deploymentcables 250 (“deployment wire”) from suture loops 426, 428.

In some example embodiments, alternatives to suture loops 426, 428 anddeployment cable 250 may be utilized to releasably retain occlusion clip1000 in jaws 402, 404. For example, slip knots, interference fits,suture cutting, and/or pull cords may be used.

The present disclosure contemplates that some occlusion deviceapplicators may be provided with an end effector that is fixed (e.g.,not rotatable) with respect to the handle. As a result, rotating the endeffector (and attached occlusion clip) requires the user to rotate thehandle. The present disclosure contemplates that providing an occlusiondevice applicator with a rotatable shaft may provide ergonomicadvantages for the user and/or may better accommodate both left-handedand right-handed use. Additionally, the present disclosure contemplatesthat an occlusion device applicator with a rotatable shaft may reducethe difficulty of accessing the desired occlusion site, particularly inconnection with anatomical structures that may vary in location and/ororientation from patient to patient. Further, the present disclosurecontemplates that providing an occlusion device applicator with arotatable shaft may allow the device to be packaged in a smallerconfiguration than the configuration in which it may be used. Thepresent disclosure contemplates that a smaller packaging configurationmay be advantageous for shipping, storage, and/or sterilization, forexample.

FIG. 15 is a detailed perspective view of a distal portion of an examplehandle 200, according to at least some aspects of the presentdisclosure. FIG. 16 is a detailed perspective view of a proximal portionof an example shaft 300, according to at least some aspects of thepresent disclosure. FIG. 17 is a detailed internal perspective view ofan example shaft 300 and handle 200 in a locked configuration, accordingto at least some aspects of the present disclosure. FIG. 18 is adetailed internal perspective view of an example shaft 300 and handle200 in an unlocked configuration, according to at least some aspects ofthe present disclosure. FIG. 19 is an internal perspective view of adistal portion of an example handle with an example shaft in a rotatedconfiguration, according to at least some aspects of the presentdisclosure.

Referring to FIG. 16, an example shaft 300 may include a generallycylindrical body with a generally longitudinal channel 308 extendingtherethrough, generally in the form of a tube 306. Activation cable 210(FIGS. 6-8) and/or deployment cable 250 (FIGS. 11-14) may extenddistally through channel 308 of tube 306 from handle 200 to end effector400. End effector 400 may be disposed on a distal portion of tube 306and shaft rotation knob 302 may be disposed on a proximal portion oftube 306.

Referring to FIGS. 15-18, handle 200 and shaft rotation knob 302 mayinclude releasably engageable corresponding locking features arranged toselectively inhibit rotation of shaft 300 with respect to handle 200.Referring to FIG. 15, in some example embodiments, a distal face 274 ofhandle 200 (e.g., shells 201, 203) may include a locking feature, suchas a locking recess 276. Locking recess 276 may include a plurality ofgenerally radially inwardly facing locking faces 278. In some exampleembodiments, locking recess 276 may be generally octagonally shaped,with eight locking faces 278 disposed substantially evenlycircumferentially to at least partially define locking recess 276.

Referring to FIGS. 16-18, in some example embodiments, a proximal face310 of shaft rotation knob 302 may include a locking feature, such asproximally projecting locking boss 312. Locking boss 312 may include aplurality of generally radially outwardly facing locking faces 314. Insome example embodiments, locking boss 312 may be generally octagonallyshaped, with eight locking faces 314 disposed substantially evenlycircumferentially to at least partially define locking boss 312.

In some example embodiments, locking boss 312 and locking recess 276 maybe sized and shaped such that locking boss 312 may be slidably receivedat least partially within locking recess 276. Respective outwardlyfacing locking faces 314 of locking boss 312 may generally align withand axially slidably engage with respective inwardly facing lockingfaces 278 of locking recess 276.

Referring to FIGS. 16-18, shaft 300 may include a compression spring 316disposed coaxially around tube 306 proximally from shaft rotation knob302. Spring 316 may be restrained on tube 306 proximally by a retainer,such as retainer clip 318, which may be affixed to tube 306 atcircumferential groove 320. At its distal end, spring 316 may pressagainst a bushing 322, which may be slidably disposed coaxially aroundtube 306 between shaft rotation knob 302 and spring 316 (e.g.,proximally of shaft rotation knob 302 and distally of spring 316).

Referring to FIGS. 17 and 18, handle 200 (e.g., shell 201 and/or shell203) may include a spring stop feature, such as laterally disposedinternal wall 280, which may be arranged to engage and oppose distalmovement of bushing 322. Spring 316 may press apart bushing 322 andretainer clip 318, which may bias tube 306 in the proximal directionrelative to handle 200.

In the locked configuration (FIG. 17), spring 316 may be at leastpartially extended and locking boss 312 of shaft rotation knob 302 maybe at least partially engaged proximally within locking recess 276 ofhandle 200. Accordingly, rotation of shaft 300 relative to handle 200may be prevented by the engagement of outwardly facing locking faces 314of locking boss 312 with respective inwardly facing locking faces 278 oflocking recess 276. In some example embodiments, proximal face 310 ofshaft rotation knob 302 may contact distal face 274 of handle 200 whenshaft rotation knob 302 is in the locked configuration.

To shift from the locked configuration (FIG. 17) to the unlockedconfiguration (FIG. 18), a user may apply a generally distal force onshaft rotation knob 302, moving shaft 300 distally relative to handle200 by overcoming the force of spring 316. In the unlocked configuration(FIG. 18), spring 316 may be at least partially compressed and lockingboss 312 of shaft rotation knob 302 may be substantially disengageddistally from locking recess 276 of handle 200. Accordingly, shaft 300may be rotatable with respect to handle 200, such as by a user rotatingshaft rotation knob 302.

To shift from the unlocked configuration (FIG. 18) to the lockedconfiguration (FIG. 17), shaft rotation knob 302 moves proximallyrelative to handle 200 to at least partially engage locking boss 312 ofshaft rotation knob 302 within locking recess 276 of handle 200. In someexample embodiments, the force exerted by spring 316 may be sufficientto shift from the unlocked configuration to the locked configurationwhen the user-applied distal force is removed from shaft rotation knob302.

FIG. 19 shows an example shaft 300 in a rotated configuration with shaftrotation knob 302 in a locked configuration. Compare the position of endeffector 400 in FIG. 2 and FIG. 19. In some alternative exampleembodiments according to at least some aspects of the presentdisclosure, shaft 300 may be rotatably mounted to handle 200 in a mannerthat allows the user to adjust the degree of rotation to any angle(within a maximum rotation range) without being limited to locking atpredetermined rotation increments. See, for example, FIG. 32 and thecorresponding description of an alternative shaft rotation featureincluding a friction spring, below.

Referring to FIGS. 15-19, in some example embodiments includinggenerally octagonal locking features (e.g., locking recess 276 and/orlocking boss 312), shaft 300 may be lockable in angular positions thatare about 45 degrees apart. It is within the scope of the presentdisclosure to utilize corresponding locking features (e.g., lockingrecess 276 and/or locking boss 312) having shapes other than generallyoctagonal. For example, corresponding locking features may be generallytriangular, square, pentagonal, hexagonal, heptagonal, nonagonal, ordecagonal, and/or shaped in general as any other substantiallyrotationally symmetric polygon.

Referring to FIGS. 15, 16 and 19, an example shaft rotation knob 302 mayinclude a rotation limiting feature, such as a stop 324. Stop 324 mayinclude one or more stop faces 326, 328, which may be disposed to engagea rotation limiting feature, such as generally longitudinally extendingbar 282 disposed on handle 200 (e.g., on shell 201), when shaft rotationknob 302 is rotated a predefined maximum desired amount. For example,stop face 326 may engage bar 282 and prevent further rotation when shaftrotation knob 302 is rotated about 90 degrees clockwise when lookingdistally. Stop face 328 may engage bar 282 and prevent further rotationwhen shaft rotation knob 302 is rotated about 90 degreescounterclockwise when looking distally. Accordingly, in some exampleembodiments, shaft rotation knob 302 (and shaft 300) may be rotatableover about 180 degrees. In some example embodiments including generallyoctagonal locking features (e.g., locking recess 276 and/or locking boss312) and rotation limiting features allowing about 180 degrees ofrotation, shaft 300 may be lockable in five angular positions that areabout 45 degrees apart.

In some example embodiments, rotation of shaft 300 may be inhibited whenclip applier 100 is in the open configuration (FIG. 2). For example,when activation lever 204 is in the open configuration, activation cable210 may be pulled tight, which may prevent distal movement of shaft 300relative to handle 200. Accordingly, shifting from the lockedconfiguration (FIG. 17) to the unlocked configuration (FIG. 18) may beprevented.

FIG. 20 is a side elevation view of clip applier 100 with shaft 300 in abent configuration, according to at least some aspects of the presentdisclosure. In some example embodiments, shaft 300 may malleable (e.g.,plastically deformable) such that it may be reshaped by a user to adaptthe shape of shaft 300 to better accommodate specific patient anatomies.For example, shaft 300 may be configured to permit adjustment by bendingat an angle 304 with respect to an unbent configuration (e.g., FIG. 2).In some example embodiments, shaft 300 may be configured to allowbending up to an angle 304 of about 45 degrees in any direction. Someexample clip appliers 100 may be configured by a user to adapt tospecific patient anatomies by both rotating shaft 300 and bending shaft300. In some example embodiments, shaft 300 may be bent in differentshapes, may be bent in more than one direction, and/or may be bent inany manner necessary to provide enhanced access to the occlusion site ofa particular patient.

In some example embodiments, shaft 300 may be constructed of a materialwith a relatively low yield strength and a high elongation percentage.For example, 1100 aluminum may have a yield strength of about 5,000 psiand/or may have an elongation percentage of about 35%, 3003 aluminum mayhave a yield strength of about 6,000 psi and/or an elongation percentageof about 30%. 5052 Aluminum) One of skill in the art will recognize thatselecting a material with a particular yield strength in conjunctionwith the dimensions of the shaft may achieve desired properties. Forexample, some embodiments may be configured to permit bending by handand retaining the shape (e.g., plastically deforming the shaft). In someexample embodiments, selecting a material with a high elongationpercentage may allow multiple bends without breaking. In some exampleembodiments, the shaft 300 material may have a strength less than about28,000 psi and/or may have an elongation percentage greater than about12%. In some example embodiments, shaft 300 may be constructed of othermetals, such as aluminum 5052, copper, stainless steel (e.g., annealedthin walled). In some example embodiments, shaft 300 may be constructedof deformable plastic, such as polycarbonate.

The following description includes various alternative example featuresand embodiments. One of skill in the art will recognize that these andother alternative example features and embodiments may be used inaddition to and/or in place of various features and embodimentsdescribed elsewhere in the present disclosure.

FIG. 21 is a detailed internal perspective view of alternative exampleocclusion clip release components in a during deployment configuration.In some example embodiments, crimp sleeve 264 on deployment cable 250may be longitudinally slidably disposed within, but restrained laterallyby, a fixed slot 284, which may be fixedly disposed inside handle 200A.A movable anchoring plate 286 including a slot 288 may be arranged toprevent proximal movement of crimp sleeve 264 in a before deploymentconfiguration. For example, crimp sleeve 264 may at least partially abutanchoring plate 286. A user-activated deployment trigger, such asdeployment button 290 may be pivotably disposed on handle 200A and maybe operatively coupled to anchoring plate 286. Upon actuation ofdeployment button 290, such as by it being pressed by a user's thumb,anchoring plate 286 may move to the during deployment configurationshown in FIG. 21, in which an opening 292 is aligned with crimp sleeve264, allowing crimp sleeve 264 to move proximally relative to fixed slot284 and/or anchoring plate 286. For example, crimp sleeve 264 may moveat least partially through opening 292 of anchoring plate 286. In someexample embodiments, the other occlusion clip release components mayoperate substantially similarly to those described in connection withFIGS. 11-13.

FIGS. 22-24 are perspective views, according to at least some aspects ofthe present disclosure, of alternative example locations andconfigurations for user-activated deployment triggers, such asdeployment buttons 290A, 290B, 290C, which may operate substantiallysimilarly to user-activated deployment button 290 described inconnection with FIG. 21 or deployment trigger 206 (FIGS. 11-13).

FIG. 25 is a perspective view of an alternative example clip applier 600including a thumbwheel deployment cable retractor 602, according to atleast some aspects of the present disclosure. In some alternativeembodiments, a thumbwheel retractor mechanism may be used to retractdeployment cable 250 in place of a mechanism including deploymenttrigger 206, anchoring plate 262, and extension spring 256 and relatedcomponents. Generally, rotation of a thumbwheel 602 (such as by a user'sthumb) may retract deployment cable 250. In some example embodiments, athumbwheel mechanism may facilitate one-handed operation and/or mayallow for improved control of the clip applier 600.

FIG. 26 is a perspective view of an alternative example clip applier 604including a lever actuated deployment cable retractor, according to atleast some aspects of the present disclosure. In some exampleembodiments, clip applier 604 may include a deployment lever 606, whichmay be placed in an ergonomically appropriate location and/or which maybe pivoted by a user to retract deployment cable 250. In some exampleembodiments, a pulley system may be used to increase the stroke lengthrequired to retract the cable past the suture loops. Some exampleembodiments including a lever actuated deployment cable retractor mayfacilitate one-handed operation and/or improved control of the clipapplier 604. In some example embodiments, deployment lever 606 may bedisposed in a location that may be protected from inadvertent operationby a trigger guard 608. Similar trigger guards 608 may be used withother example clip appliers according to the present disclosure. In somealternative embodiments, a lever actuated deployment cable retractor maybe used to retract deployment cable 250 in place of a mechanismincluding deployment trigger 206, anchoring plate 262, and extensionspring 256 and related components.

FIG. 27 is a perspective view of an alternative example clip applier 610including a pull tab 612 deployment cable retractor, according to atleast some aspects of the present disclosure. In some exampleembodiments, pull tab 612 may include a hole that can readily bemanipulated, such as with one finger. Pull tab 612 may be actuated usinga twisting motion to free (e.g., unlock) pull tab 612. For example, pulltab 612 may be rotated clockwise or counterclockwise by a predeterminedamount, which may be about 45 to about 90 degrees. Then, pull tab 612may be pulled proximally to withdraw deployment cable 250 and releasethe occlusion device. In some example embodiments, one or more ears ofpull tab 612 may lock into the handle when pull tab 612 is in a lockedconfiguration. Turning pull tab 612 may release the ears, allowing asmooth withdrawal of deployment cable 250. In some example embodiments,pull tab 612 may include a detent feature to reduce the risk ofinadvertent rotation during shipping and/or use. In some exampleembodiments, a pull tab 612 using a rotation motion for unlocking and aproximal motion for cable 250 withdrawal may provide improved ergonomicsand/or may reduce a jerking motion experienced with some clip appliersthat use a straight pull unlocking motion. In some alternativeembodiments, a pull tab deployment cable retractor may be used toretract deployment cable 250 in place of a mechanism includingdeployment trigger 206, anchoring plate 262, and extension spring 256and related components.

FIG. 28 is a side elevation view of an alternative example clip applier614 including a torsion spring cable retractor, according to at leastsome aspects of the present disclosure. Some example embodiments mayoperate generally similar to a retractable tape measure. In some exampleembodiments, a torsion spring 616 may be operatively coupled to a spool618, which may receive deployment cable 250. Clip applier 614 may beprovided with torsion spring 616 pre-torsioned so that spool 618 appliesproximal tension on deployment cable 250. A retainer 620 may selectivelyprevent proximal withdrawal (e.g., retraction) of deployment cable 250until retainer 620 is disengaged by a user, such as by pressing adeployment button 622. In some alternative embodiments, a torsion springcable retractor may be used to retract deployment cable 250 in place ofa mechanism including deployment trigger 206, anchoring plate 262, andextension spring 256 and related components. It is within the scope ofthe present disclosure to utilize a torsion spring cable retractor in anocclusion device application with any handle style, including pistolgrip, plunger, and/or ambidextrous handheld.

FIGS. 29-31 are side elevation views of example methods for attachingstrands 251, 253 of deployment cable 250 to torsion spring 616,according to at least some aspects of the present disclosure. FIG. 29illustrates attachment using a crimp plate 634, which may couple strands251, 253 of deployment cable 250 to torsion spring 616. FIG. 30illustrates attachment using solder 636, which may couple strands 251,253 of deployment cable 250 to torsion spring 616. FIG. 31 illustratesattachment using a fastener 638 (such as a rivet or similar fastener),which may couple strands 251, 253 of deployment cable 250 to torsionspring 616.

FIG. 32 is a detailed perspective view of an alternative shaft rotationfeature including a friction spring, according to at least some aspectsof the present disclosure. In some example embodiments, a proximalportion of shaft 300A (such as proximal portion of shaft rotation knob302A) may include an outer surface 350, which may be configured toreceive a looped section 354 of friction spring 352 thereabout. Atangentially extending tab 356 of spring may engage an internal featureof handle 200 to prevent rotation of spring 352 relative to shells 201,203. The fit of loop section 354 of friction spring 352 on surface 350may be a press fit (e.g., about 0.010″), which may provide sufficientfriction between loop section 354 and surface 350 to reduce unwantedrotation but may allow a user to rotate shaft 300A by rotating shaftrotation knob 302A with sufficient torque when desired. One of skill inthe art that the friction may be increased or decreased based on thediameter of the spring and/or by the press fit dimension. In someexample embodiments, utilizing a friction spring shaft rotation featuremay be desirable because it may not require additional controls or partsto facilitate rotation of shaft 300A. In some alternative embodiments, afriction spring shaft rotation feature may be used in place of amechanism including locking recess 276, locking boss 312, and/or relatedcomponents.

FIG. 33 is a detailed perspective view of an alternative shaft rotationfeature including a detent mechanism, according to at least some aspectsof the present disclosure. In some example embodiments, a proximal endof shaft rotation knob 302B disposed on a shaft 300B may include aproximally extending lock projection 358, which may include a pluralityof faces 360. A locking spring 362 may elastically engage one or morefaces 360. Locking spring 362 may include a tangentially extending tab364 that may engage an internal feature of handle 200 such that spring362 is not rotatable relative to handle 200. In some exampleembodiments, the engagement of locking spring 362 with one or more faces360 may reduce unwanted rotation of shaft 300B but may allow a user torotate shaft 300B by rotating shaft rotation knob 302B with sufficienttorque to overcome locking spring 362 when desired. When rotated by auser, locking spring 362 may elastically deform to allow rotation oflock projection 358, disengaging from one face 360, then elasticallyengaging an adjacent face 360. In some example embodiments, utilizing adetent mechanism shaft rotation feature may be desirable because it maynot require additional controls or parts to facilitate rotation of shaft300B. In some alternative embodiments, a detent mechanism shaft rotationfeature may be used in place of a mechanism including locking recess276, locking boss 312, and/or related components.

Some example embodiments may include a removable safety device arrangedto prevent deployment of an occlusion clip prior to the intendeddeployment. For example, a safety device may reduce the likelihood ofaccidental deployment of the occlusion clip during manufacture,inspection, transit, and/or handling. FIG. 34 is a perspective view ofan example clip applier including a lateral safety tab 624 according toat least some aspects of the present disclosure. Lateral safety tab 624may include an outwardly extending grip 626 that may be grasped by auser coupled to a laterally extending pin 628, which may extend at leastpartially into and/or through handle 200B. Pin 628 may releasably engagethe occlusion clip deployment mechanism within handle 200B to blockoperation of the user-activated trigger or button and/or preventactuation of the mechanism until lateral safety tab 624 is withdrawnlaterally from handle 200B.

FIG. 35 is a perspective view of an example clip applier including alongitudinal safety tab 630 according to at least some aspects of thepresent disclosure. Longitudinal safety tab 630 may include an outwardlyextending grip 632 that may be grasped by a user coupled to alongitudinally extending portion (e.g., a pin) (not shown), which mayextend at least partially into and/or through handle 200C. Safety tab630 may releasably engage the occlusion clip deployment mechanism withinhandle 200C to block operation of the user-activated trigger or buttonand/or prevent actuation of the mechanism until longitudinal safety tab630 is withdrawn longitudinally from handle 200C.

In some example embodiments, safety tabs 624, 630 may be easilyidentifiable, such as by color or other markings. In some exampleembodiments, a safety tab 624, 630 may block operation of the clipdeployment mechanism (in addition to blocking operation of theuser-activated trigger or button), which may inhibit inadvertentactuation of the deployment mechanism due to inertia, such as if theclip applier is dropped.

FIGS. 36-37 are interior perspective views of example shells 201, 203 ofhandle 200, according to at least some aspects of the presentdisclosure. As described elsewhere in the present disclosure, shells201, 203 may include bearings 205, 207, 209, 211, boss 258, anchoringplate slots 213, 215, track 226, first sidewall 228, second sidewall230, wall 280, and/or bar 282.

U.S. Pat. No. 9,901,352, titled “Occlusion Clip” and incorporated hereinby reference, describes example occlusion clips that may be used with atleast some embodiments according to the present disclosure. Some exampleembodiments according to at least some aspects of the present disclosuremay be configured for use with clips that are open-ended, closed-biased,and/or close tip-first. Some example embodiments may be used withclosed-ended occlusion clips.

In some example embodiments, clip applier 100 may be a single-use (e.g.,disposable) device and/or occlusion clip 1000 may be provided pre-loadedon clip applier 100. Some example clip appliers 100 may be provided withpre-loaded occlusion clips 1000 of different sizes, allowing a user toselect an appropriate clip applier 100 with pre-loaded clip 1000 of asize appropriate for a particular patient. For example, a selection ofclip appliers 100 having a pre-loaded occlusion clips 1000 that are 35mm, 40 mm, 45 mm, and/or 50 mm in size may be provided.

The present disclosure contemplates that some medical devices, such assome example clip appliers 100 according to the present disclosure, mayrequire sterilization prior to use. Accordingly, some exampleembodiments may be constructed from materials that may be compatiblewith various sterilization methods, such as gamma sterilization. Forexample, handle shells 201, 203, activation lever 204, deploymenttrigger 206, and/or shaft rotation knob 302 may be constructed frominjection molded plastic. For example, shaft 300, linkage 212,activation cable 210, deployment cable 250, crimp sleeves 222, 264,extension spring 256, and/or anchoring plate 260 may be constructed frommetals. In some example embodiments, metals may be selected to providecorrosion resistance, such as aluminum and/or stainless steel. In someexample embodiments, metals may receive surface treatments, such asanodization and/or passivation, to provided added corrosion resistance.

It is within the scope of the present disclosure to utilize theapparatus and methods described herein in connection with any anatomicalstructure that may be occluded, including anatomical structures otherthan LAAs.

Following from the above description and invention summaries, it shouldbe apparent to those of ordinary skill in the art that, while themethods and apparatuses herein described constitute example embodimentsaccording to the present disclosure, it is to be understood that thescope of the disclosure contained herein is not limited to the aboveprecise embodiments and that changes may be made without departing fromthe scope as defined by the following claims. Likewise, it is to beunderstood that it is not necessary to meet any or all of the identifiedadvantages or objects disclosed herein in order to fall within the scopeof the claims, since inherent and/or unforeseen advantages may existeven though they may not have been explicitly discussed herein.

What is claimed is:
 1. A medical instrument, comprising: a handle; anactivation lever disposed on the handle, the activation lever beingmovable between a closed activation lever configuration and an openactivation lever configuration by application of an external force tothe activation lever; a shaft mounted to and extending distally from thehandle; and an end effector disposed distally on the shaft, the endeffector comprising a first jaw movable between a closed jawconfiguration and an open jaw configuration, the first jaw beingoperatively coupled to the activation lever such that moving theactivation lever from the closed activation lever configuration to theopen activation lever configuration moves the first jaw from the closedjaw configuration to the open jaw configuration; wherein the activationlever and handle include a track and a track follower configured todecrease an external force required to move the activation lever fromthe closed activation lever configuration to the open activation leverconfiguration as the activation lever moves from the closed activationlever configuration to the open activation lever configuration; andwherein the first jaw is configured to releasably receive an occlusionclip.
 2. The medical instrument of claim 1, wherein an external forcerequired to maintain the activation lever in the open activation leverconfiguration is less than the external force required move theactivation lever from the closed activation lever configuration to theopen activation lever configuration.
 3. The medical instrument of claim2, wherein the external force required to maintain the activation leverin the open activation lever configuration is less than about one halfof the external force required move the activation lever from the closedactivation lever configuration to the open activation leverconfiguration.
 4. The medical instrument of claim 1, wherein an externalforce required move the activation lever from the closed activationlever configuration to the open activation lever configuration issubstantially constant for about 85% of a length of travel from theclosed activation lever configuration to the open activation leverconfiguration.
 5. The medical instrument of claim 1, wherein theactivation lever is pivotably disposed on the handle; and wherein thefirst jaw is pivotably disposed on the end effector.
 6. The medicalinstrument of claim 1, wherein the activation lever is operativelycoupled to the first jaw by an activation cable extending through theshaft.
 7. The medical instrument of claim 6, further comprising alinkage, the linkage comprising a first end pivotably attached to theactivation lever and a second end having the track follower affixedthereto; and the track is disposed within the handle and configured toslidably receive the track follower; wherein the activation cable ismounted to the second end of the linkage and extends to the end effectorthrough a channel in the shaft; wherein moving the activation leverbetween the closed activation lever configuration and the openactivation lever configuration by application of the external force tothe activation lever moves the track follower along the track from afirst location to a second location; wherein moving the track followerfrom the first location to the second location pulls the activationcable generally proximally; and wherein pulling the activation cableproximally causes the end effector to move the first jaw from the closedjaw configuration to the open jaw configuration.
 8. The medicalinstrument of claim 7, wherein the track is generally arcuately shaped.9. The medical instrument of claim 7, wherein a pivot point of theactivation lever, a direction of the activation cable generally betweenthe second end of the linkage and the pivot point of the activationlever, and the track follower are generally aligned when the activationlever is in the open activation lever configuration.
 10. The medicalinstrument of claim 1, further comprising a spring operatively coupledto the activation lever and the linkage to bias the activation levertowards the closed activation lever configuration.
 11. The medicalinstrument of claim 1, further comprising an occlusion clip releasablyattached to the end effector; wherein the occlusion clip moves from aclosed occlusion clip configuration to an open occlusion clipconfiguration as the first jaw moves from the closed jaw configurationto the open jaw configuration.
 12. The medical instrument of claim 11,wherein the occlusion clip is an open-ended occlusion clip; and whereinthe occlusion clip is biased toward the closed occlusion clipconfiguration.
 13. The medical instrument of claim 1, wherein, when theactivation lever is in the open activation lever position and theexternal force is removed, the activation lever moves to the closedactivation lever position, the track follower moves from the secondlocation to the first location, and the first jaw moves from the openjaw configuration to the closed jaw configuration without application ofan external force.
 14. The medical instrument of claim 1, wherein theshaft is mounted to the handle such that the shaft is selectivelyrotatable relative to the handle.
 15. The medical instrument of claim14, wherein the handle and the shaft each comprise a releasablyengageable corresponding locking feature arranged to selectively inhibitrotation of the shaft relative to the handle.
 16. The medical instrumentof claim 1, wherein the shaft is plastically deformable.
 17. The medicalinstrument of claim 1, wherein the shaft is plastically deformable up toan angle of at least about 45 degrees.
 18. The medical instrument ofclaim 1, further comprising an occlusion clip releasably attached to theend effector; and a deployment trigger disposed on the handle, thedeployment trigger being movable between a pre-deployment configurationand a deployment configuration by application of an external force tothe deployment trigger, the deployment trigger being operable to releasethe occlusion clip from the end effector.
 19. The medical instrument ofclaim 1, further comprising a deployment cable extending from the handleto the first jaw, the deployment cable being operative, when retracted,to release an occlusion clip from the first jaw; and at least one of athumbwheel disposed on the handle, the thumbwheel being operable toretract the deployment cable and release the occlusion clip; adeployment lever disposed on the handle, the deployment lever beingoperable to retract the deployment cable and release the occlusion clip;a rotatable pull tab disposed on the handle, the pull tab beingoperable, after being rotated, to retract the deployment cable andrelease the occlusion clip; and a torsion spring cable retractorcomprising a torsion spring arranged to apply proximal tension ondeployment cable and a retainer arranged to selectively preventretraction of deployment cable until the retainer is disengaged, thetorsion spring cable retractor being operable to retract the deploymentcable and release the occlusion clip. 20.-32. (canceled)
 33. A medicalinstrument, comprising: a handle; a plastically deformable shaft mountedto and extending distally from the handle; and an end effector disposeddistally on the shaft and configured to releasably receive an occlusionclip thereon, wherein the shaft is mounted to the handle such that theshaft is selectively rotatable relative to the handle.
 34. The medicalinstrument of claim 33, wherein the handle comprises a handle lockingfeature; wherein the shaft comprises a shaft locking featurecorresponding to the handle locking feature; and wherein the handlelocking feature and the shaft locking feature are releasably engageableto selectively inhibit rotation of the shaft relative to the handle. 35.The medical instrument of claim 34, wherein one of the handle lockingfeature and the shaft locking feature comprises a locking recesscomprising a plurality of inwardly facing locking recess locking faces;wherein the other of the handle locking feature and the shaft lockingfeature comprises a projecting locking boss comprising a plurality ofradially outwardly facing locking boss faces; and wherein, in a lockedconfiguration, the locking boss is at least partially engaged within thelocking recess, inhibiting rotation of the shaft relative to the handle.36. The medical instrument of claim 35, wherein the handle lockingfeature comprises a generally octagonally shaped locking recess disposedon a distal face of the handle; and wherein the shaft locking featurecomprises a generally octagonally shaped, proximally projecting lockingboss.
 37. The medical instrument of claim 35, further comprising aspring operatively disposed on the handle and the shaft to bias theshaft and the handle toward the locked configuration.
 38. The medicalinstrument of claim 33, wherein at least one of the shaft and the handlecomprises a rotation limiting feature that prevents rotation of theshaft relative to the handle beyond a predetermined maximum amount. 39.The medical instrument of claim 38, wherein the rotation limitingfeature comprises on the handle, a generally longitudinally extendingbar; and on the shaft, a stop comprising at least one stop face arrangedto engage the bar and prevent further rotation when the shaft is rotateda predetermined maximum amount.
 40. The medical instrument of claim 33,further comprising a friction spring in a press fit engagement with asurface of the shaft, the friction spring including a tab engaging thehandle to prevent rotation of the friction spring relative to thehandle; wherein the press fit engagement between the friction spring andthe surface of the shaft opposes rotation of the shaft relative to thehandle but allows such rotation when sufficient torque is applied to theshaft.
 41. The medical instrument of claim 33, wherein the shaftcomprises a proximally extending lock projection comprising a pluralityof locking faces; wherein the handle comprises a locking spring arrangedto elastically engage at least one of the locking faces; and wherein theelastic engagement of the locking spring and the locking faces opposesrotation of the shaft relative to the handle but allows such rotationwhen sufficient torque is applied to the shaft.
 42. The medicalinstrument of claim 33, wherein the shaft comprises at least one ofaluminum, copper, stainless steel, and polycarbonate.
 43. The medicalinstrument of claim 33, wherein the shaft is deformable up to an angleof at least about 45 degrees.
 44. The medical instrument of claim 33,further comprising a deployment trigger disposed on the handle, thedeployment trigger being movable between a pre-deployment configurationand a deployment configuration by application of an external force tothe deployment trigger, the deployment trigger being operable to releasean occlusion clip from the end effector.
 45. The medical instrument ofclaim 33, wherein the end effector comprises a first jaw movable betweena closed jaw configuration and an open jaw configuration.
 46. Themedical instrument of claim 45, further comprising an activation leverdisposed on the handle, the activation lever being movable between aclosed activation lever configuration and an open activation leverconfiguration by application of an external force to the activationlever; wherein the first jaw is operatively coupled to the activationlever such that moving the activation lever from the closed activationlever configuration to the open activation lever configuration moves thefirst jaw from the closed jaw configuration to the open jawconfiguration. 47.-76 (canceled)
 77. The medical instrument of claim 38,wherein the rotation limiting feature comprises on the handle, agenerally longitudinally extending bar; and on the shaft, a stopcomprising at least one stop face arranged to engage the bar and preventfurther rotation when the shaft is rotated a predetermined maximumamount.